Last updated: April 3, 2024
Sponsor: Takeda
Overall Status: Active - Recruiting
Phase
2/3
Condition
Dementia
Mild Cognitive Impairment
Memory Problems
Treatment
Elaprase
Idursulfase-IT
Clinical Study ID
NCT06031259
TAK-609-3001
2023-504127-90
Ages 3-19 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The participant must have completed end of study assessments in studies HGT-HIT-046 [NCT01506141] or SHP609-302 [NCT02412787] and received a clinical benefit fromidursulfase-IT in the opinion of the investigator.
- The participant, or participant's legally designated representative, must have beeninformed of the nature of this open-label extension and must have voluntarily signedan Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approvedinformed consent form after all relevant aspects of the study have been explained anddiscussed. Written consent of the participant's legally designated representative (ifapplicable) and the participant's consent/assent, as relevant, must be obtained.
- The participant has continued to receive elaprase on a regular basis in studiesHGT-HIT-046 or SHP609-302.
Exclusion
Exclusion Criteria:
- The participant has experienced, in the opinion of the investigator, a safety ormedical issue that contraindicates treatment with idursulfase-IT, including, but notlimited to, uncontrolled seizure disorder, bleeding disorder, and clinically relevanthypertension.
- The participant has clinically relevant intracranial hypertension.
- The participant is enrolled in another clinical study, other than studies HGT-HIT-046or SHP609-302, that involves clinical investigations or use of any investigationalproduct (drug or [intrathecal/spinal] device) within 30 days prior to study enrolmentor at any time during the study.
Study Design
Total Participants: 8
Treatment Group(s): 2
Primary Treatment: Elaprase
Phase: 2/3
Study Start date:
March 05, 2024
Estimated Completion Date:
June 01, 2034
Study Description
Connect with a study center
M.A.G.I.C. Clinic
Calgary, Alberta T2E 7Z4
CanadaActive - Recruiting
M.A.G.I.C. Clinic LTD
Calgary, Alberta T2E 7Z4
CanadaSite Not Available
University of British Columbia
Vancouver, British Columbia V6T1Z3
CanadaSite Not Available
Hospital for Sick Children
Toronto, Ontario M5G1X8
CanadaSite Not Available
The Hospital for Sick Children
Toronto, Ontario M5G1X8
CanadaSite Not Available
Hopital Femme Mere Enfant
Bron, Auvergne-Rhone-Alpes 02 69229
FranceSite Not Available
Hospices Civils de Lyon
Lyon Cedex, 69229
FranceSite Not Available
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